The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/30/2020.H.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g bd safetygglide insulin syringe in an open blister pack from lot # 8325571.Customer states that there is an obstruction and they can¿t extract the medicine.The returned syringe was tested and was not able to draw properly.The sample was then wired and the wire was not able to pass through the cannula, indicating that there is an adhesive clog in the cannula.A review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Process: the racks carrying the hub with cannula move further down along a rail, a pullout device moves the cannula out a small distance for adhesive to be applied.During the parts pass under the corona treater pins and exposed to an ion rich corona field, which increases surface energy wettability to aid in the adhesion of the adhesive to the hub.The cannula is then re-inserted into the hub with vacuum.The pim inspection systems looks for adhesive clogs and rejects the needle assemblies in the process.Investigation: a review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Root cause: root cause cannot be determined for this complaint.
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